BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11899280 · Received May 28, 2021

    Report

    Report Number
    3003152976-2021-00295
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 16, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY FOUR UNUSED SAMPLES AND ONE USED SAMPLES WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTION, A HAIR WAS OBSERVED INSIDE THE USED SAMPLE, NO HAIR OR OTHER FOREIGN MATERIAL WAS FOUND IN THE UNUSED PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 2012065, 2009024, 2011019 AND THE ADDITIONAL UNUSED LOT 2010070 WHICH WAS ALSO RECEIVED, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. ALL INDIVIDUALS ARE REQUIRED TO FOLLOW PROPER GOWNING PROCEDURES BEFORE ENTERING THE ROOM, INCLUDING HAIR PROTECTION. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE ROOT CAUSE OF THIS INCIDENT IS DUE TO PERSONNEL NOT FOLLOWING THE PROPER GOWNING PROCEDURE. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN THREAD/HAIR WAS FOUND IN 1 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EACH FROM LOTS 2011019, 2009024, AND 2012065 AFTER DRAWING UP "NAGLAZYME INF KONS 1MG/ML, 5MLHG". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A THREAD/HAIR WAS FOUND IN THE SYRINGE AFTER THEY HAD DRAWN UP 3 VIALS OF NAGLAZYME INF KONS 1MG/ML, 5MLHGL. FOR THIS TREATMENT THEY WOULD BE DRAWING UP 8 VIALS, HAVING FOUND THE HAIR/THREAD AFTER THE THIRD VIAL HAD BEEN DRAWN UP THE EXPENSIVE MEDICATION COULD NOT BE USED ANYMORE.".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2011019. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31 DEVICE MANUFACTURE DATE: 2020-11-09. . MEDICAL DEVICE LOT #: 2009024. MEDICAL DEVICE EXPIRATION DATE: 2025-08-31. DEVICE MANUFACTURE DATE: 2020-09-10. MEDICAL DEVICE LOT #: 2012065. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-12-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN THREAD/HAIR WAS FOUND IN 1 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE EACH FROM LOTS 2011019, 2009024, AND 2012065 AFTER DRAWING UP "NAGLAZYME INF KONS 1MG/ML, 5MLHG". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A THREAD/HAIR WAS FOUND IN THE SYRINGE AFTER THEY HAD DRAWN UP 3 VIALS OF NAGLAZYME INF KONS 1MG/ML, 5MLHGL. FOR THIS TREATMENT THEY WOULD BE DRAWING UP 8 VIALS, HAVING FOUND THE HAIR/THREAD AFTER THE THIRD VIAL HAD BEEN DRAWN UP THE EXPENSIVE MEDICATION COULD NOT BE USED ANYMORE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795977 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1